The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin; Drug: Metformin

• Registration Number: NCT02765347
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-14
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2016-06
• Status Verified: 2017-10
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Type 1 diabetes mellitus;
2. Age≥12 yr;
3. Tanner sexual maturation rating 2-5;
4. HbA1c levels: 7.5%-10%;
5. MDI or CSII ≥6 months;
6. Insulin dose ≥ 0.8U/kg before the enrollment，and the dosage is stable at least >1 month（dosage change<10%）.

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Exclusion Criteria

1. Serious acute and chronic complications associated with diabetes;
2. Repeated and serious hypoglycemia episodes repeatedly;
3. Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range);
4. Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR<60ml/min/1.73m2);
5. Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III~IV;
6. Female patients who have a sex life and are not willing to use contraceptive methods;
7. Pregnancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin	Insulin	Accept insulin for 24 weeks
Metformin and Insulin	Metformin	MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g bid or tid) for 24 weeks

Primary Outcome Measures

Name	Time	Method
HbA1c	half one year

Trial Locations

Locations (1)

The Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China